Sample collection and bioluminescent sample testing system

ABSTRACT

Methods and apparatus for evaluating the quality of a sample of a product, an ingredient, an environment or process by measuring multiple parameters thereof, including light emitted from a reacting sample containing ATP, ADP, alkaline phosphatase or other parameters such as pH, temperature, conductivity, reduction potential, dissolved gases, specific ions, and microbiological count. The apparatus comprises an integrated sample testing device used to collect a sample, mix reagents, react the sample, and collect it in a measurement chamber. The apparatus also comprises an instrument having a photon detection assembly for use with the sample testing device. The instrument can also comprise one or more sensing probes and a communication port to facilitate data collection, transfer and analysis.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The disclosure is related to the field of environmental testing, forexample, the testing of food, and of materials and surfaces with whichfood comes into contact.

2. Description of the Related Art

Safety in the food, pharmaceutical and cosmetic reference industries, interms of contamination control and hygiene, utilizing HACCP (HazardAnalysis and Critical Control Point) principles, is of growing concern,not only to control the occurrence of pathogenic microorganisms, butalso in preventing hazards before they become widespread and expensiveproblems. HACCP is the science-based system accepted internationally forensuring food safety. HACCP has been adopted by the FDA and USDA as wellas by other countries. It has been endorsed by the National Academy ofSciences, the Codex Alimentarius Commission (an international foodstandard-setting organization), and the National Advisory Committee onMicrobiological Criteria for Foods. Developed nearly 30 years ago forthe space program, HACCP has proven to be effective to ensure that foodsafety hazards are controlled to prevent unsafe food from reaching theconsumer.

In the United States alone, since 1995, HACCP based systems have beenmandated for the following industries by the Federal Government:

-   -   Seafood—(21 C.F.R. Parts 123 and 1240 Procedures for the Safe        and Sanitary Processing and Importing of Fish and Fishery        Products; Final Rule) in December, 1995    -   Meat and Poultry—(9 C.F.R. Part 304, et al, Pathogen Reduction:        Hazard Analysis and Critical Control Point (HACCP) Systems;        Final Rule) in July, 1996    -   Fruit and Vegetable Juice—(21 CFR Part 120: Hazard Analysis and        Critical Control Point (HACCP); Procedures for the Safe and        Sanitary Processing and importing of Juice; Final Rule) in        January, 2001

Adoption of HACCP will continue to increase for the foreseeable future.The FDA has published an Advance Notice of Proposed Rule Making (ANPRM)for HACCP to be applied for the rest of the food industry including bothdomestic and imported food products. Also, in January 2000, the NationalConference on Interstate Milk Shipments (NCIMS) recommended the use of avoluntary HACCP Pilot Program as an alternative to the traditionalinspection system for Grade A Dairy products.

In order for a food manufacturer to effectively comply with HACCP basedrequirements or standards, it is vital that it have an effective systemin place to collect, monitor, and analyze relevant HACCP data. Thenecessity for this can be seen by examining the seven (7) HACCPprinciples that a food manufacturer has to follow:

-   -   1. Conduct a hazard analysis.    -   2. Determine the critical control points (CCP). A CCP is a        point, step or procedure in a food process where a number of        possible measurement controls can be applied and, as a result, a        food safety hazard can be prevented, eliminated, or reduced to        acceptable levels.    -   3. Establish measurement parameters and critical limits for each        CCP and identify methods for measuring the CCP. For example,        compliance with a cooking CCP may be assessed by the combination        of two indicators: time and temperature.    -   4. Monitor the CCP to ensure on-going compliance with        established critical limits. A monitoring system should not only        detect individual deviations, but also analyze data to identify        patterns of deviation that could indicate a need to reassess the        HACCP plan.    -   5. Establish corrective actions to be taken when monitoring of        important parameters shows that a critical limit has not been        met.    -   6. Maintain accurate records. Effective record keeping is a        requirement. HACCP records must be created at the time events        occur and include the parameter measurement, date, time and the        plant employee making the entry.    -   7. Verify that the system is working properly initially as well        as ongoing. These activities include calibration of the        monitoring equipment, direct observations of the monitoring        activities and a review of the records.

One essential characteristic of the HACCP system that differentiates itfrom previous inspection system(s) is that it places responsibilitydirectly on the food manufacturer to ensure food safety. Each processormust be able to identify CCPs, measure a variety of parametricindicators for each CCP (e.g. time and temperature measurements toverify a cooking process), identify deviations, perform trend analysisof deviations, and document the data to show compliance with the HACCPrequirements. Currently, there is no one single instrument or analysisprocedure available that can perform these critical and essentialfunctions. For example, a food processor is likely to use manysingle-function monitors to take isolated measurements (e.g. atemperature probe and photometer, both instruments being capable ofmeasuring parameters related to food safety, as discussed further below)and then to enter the readings manually on different data collectionsheets. Such collection procedures are tedious and highly subject tohuman error. In addition, examination of the relationship of multipleparameters to the quality of the production environment is difficult ifnot nearly impossible. There is a need for a simple and efficient way tocollect, store, integrate, and analyze selected CCP in a format that canbe directly used to comply with HACCP based requirements and standards.

It is not surprising that the growing reach of HACCP based monitoringprograms is progressing concurrently with a trend toward methods oftesting that are improved by being more rapid, more sensitive and easierto perform. More stringent standards, such as those associated withHACCP based programs, are expected to motivate such improvements inmethods of testing. The reverse is also true in that as test methodsimprove, standards are likely to become more stringent since compliancecan be more accurately, precisely, and efficiently maintained andverified.

This trend toward improved testing of the manufacturing environment isoccurring in a wide variety of industries, including, but not limitedto, those industries related to food, pharmaceuticals, cosmetics, andmedical areas. In such industries, many techniques are used to monitorlevels of environmental quality including techniques that usemicrobiological cultures. Microbiological cultures are a most widelyconducted test method, but due to their low-test throughput capacity andlong incubation time periods, are of limited use. They cannot measurethe quality of the environment immediately prior to commencement of anoperation. A variety of tests have been developed which detect and insome cases quantify specific pathogens. They can range fromhigh-throughput automated systems to single-sample test devices. Thesemethods require the growth of microorganisms for detection, whichconsumes considerable time. Some techniques such as adenosinetriphosphate (ATP) and alkaline phosphatase (AP) measure parameters thatindirectly correlate to the level of environmental contamination. Stillothers monitor factors related to risk of the presence and propagationof microorganisms, i.e. temperature, pH, conductivity, reductionpotential, dissolved gases, total solids and protein residues. Thelatter types of methods approach real-time in their determinations,offering a distinct advantage for the user in obtaining criticalenvironmental quality information on an immediate basis.

Typically, ATP and AP and similar targets of detection usebioluminescent techniques. The protocol involves using a device tocollect a sample from a surface of interest, and activation of thedevice to mix reagents together with the sample to produce lightproportional to the amount of ATP/AP sampled. The reaction is then readby inserting the device into a photon-measuring instrument.

One bioluminescent ATP monitoring system is the LIGHTNING systemdeveloped by IDEXX LABORATORIES. The device contains a pre-moistenedswab, buffer in a bulb at one end and lyophilized reagent in a foilsealed compartment at the reading end. The swab is removed from thedevice, used to collect a sample from a test surface, and returned tothe tube of the device. The bulb is then bent to break open a snapvalve, which releases the buffer into the reading chamber when the bulbis squeezed. The sample containing swab is then pushed through a foilbarrier, the device is shaken and the reaction proceeds between ATP onthe swab and the dissolved (in the buffer) reagent. The device isinserted into the reading chamber of the photon measuring instrument anda reading is taken over a ten-second integration period. The intensityof the bioluminescent signal is proportional to ATP on the swab.

Another system presently in use is called the CHARM SCIENCES POCKETSWABPLUS. It is an integrated device used with a LUMINATOR T or a Fireflyportable luminometer. The device contains a pre-moistened swab. It isremoved from the device base, used to swab a surface, returned to thebase, then activated by screwing the top portion relative to the base.This action causes the swab tip to puncture separation barriers allowingseparate reagents to migrate to the bottom chamber of the base, mixingand reacting with the sample collected on the swab. Shaking is requiredto facilitate reagent transfer to the bottom and mixing in the bottomchamber.

The activated device is then inserted into a hole in the top of theluminometer and pushed down until it meets a stop. This processdisplaces a door. The upper portion of the device remains exterior tothe instrument, but forms a seal with the reading chamber orifice. Aread button in the instrument is then pressed to initiate a signalintegration period before a reading is displayed in relative light units(RLU).

Another such system is the BIOTRACE CLEAN-TRACE RAPID CLEANLINESS TESTself-contained device for use with the UNI-LITE XCEL portableluminometer. It also has a pre-moistened swab, which is removed, asample is collected, and the swab returned. Activation involves forcingthe top portion of the device, which contains the sample, down into thebase, through membrane-barriers. The swab engages a piercing tip, whichbreaks the membranes and allows the reagents to mix in a manner similarto that of the CHARM device. Shaking is required to transfer all of thesolution to the bottom.

The BIOTRACE luminometer has a cap, which lifts and swivels out of theway to expose the reading chamber. The sample-containing device islowered into the chamber and the cap is closed. Full closure of the capopens a light blocking member to allow signal measurement. Like theCHARM unit, a button begins the read cycle, which ends with the lightreading display in RLUs.

MERCK also offers a hygiene monitoring system for ATP that utilizes theHY-LITE Monitor along with HY-LITE test swabs, rinse tubes and samplingpens. The swab is moistened in the rinse tube. A surface is swabbed. Theswab is returned to the tube and rotated for several seconds to releaseany collected ATP. The swab is squeezed out and removed. Then the pen isinserted for one second to pick up the sample. The tip of the pen isstruck on a hard pad to engage the cuvette. A button is pushed torelease the reagents and initiate the reaction in the cuvette. Thecuvette is then removed and shaken, it is inserted into the monitor'sreading chamber, and a button is pressed to initiate a ten second lightintegration period. RLUs are then displayed on the monitor screen. Asimilar system has been developed by CELSIS also know as Hygenia calledthe SYSTEMSURE portable hygiene monitoring system. The test sequence issimilar to that of the MERCK system where the swab is moistened and thesurface is swabbed. The reagent is then pipetted into the cuvette. Theswab is inserted into the cuvette and rotated for several seconds thenremoved. The cuvette is capped and inserted into the luminometer, wherethe reading is initiated.

There is a need for an improved method and apparatus that is designed toenhance ease of use, and improve measurement accuracy and precision. Thecurrent systems incorporate unnecessary actions by the operators thatare burdensome with respect to certain steps such as pre-moistening,pipetting, rotating, two-handed screwing, two-handed pushing, striking,shaking, and precise timing, which do not adequately control deviceactivation and contribute to increased reading variances.

The present invention provides multiple embodiments of methods andapparatus to overcome several of the aforementioned limitations ofexisting systems.

BRIEF SUMMARY OF THE INVENTION

This invention is directed toward various embodiments of a monitoringassembly. The assembly comprises an instrument and probe assembly, orsample testing device, that can be used together to efficiently,accurately, and precisely measure a number of different parameters of asample for monitoring a process or environment, including luminescenceparameters. In one embodiment, the instrument comprises a photondetection assembly and the probe assembly is an integrated,self-contained, test device, for sample collection and luminescencereading with the photon detection assembly. Various embodiments ofmethods for employing the embodiments of the instrument and probeassembly are also a subject of the present invention.

The instrument can operate as a luminometer for taking light readings ofsamples contained in sample testing devices, or probes, including theprobe assembly of the present invention. In one embodiment, theinstrument has a dark reading chamber with a hinged cover, or hingedcap, connected to an elevator mechanism. The configuration of theconnection prevents the photon detector of the instrument from beingexposed to external light, even when the hinged cover is open and a testdevice is being loaded in the chamber. This is very important for signalstability and to reduce increased background photon counts, which is aprimary source of decreased system sensitivity. The hinged cover, ashutter member in the instrument, and the various components of theelevator mechanism, cooperate to block the photon detector from exposureto external light as the elevator mechanism is depressed to lower thesample-containing device, or probe, into a reading position. Also, theelevator mechanism and shutter prevent the photon detector from beingexposed to light even when the hinged cover is open and a test device isbeing loaded into the instrument. When the hinged cover is closed andthe test device is lowered, a shaft rotates to open the shutter so areading can be obtained in a previously photometrically stabilized darkenvironment.

In further embodiments, the instrument includes a communication portthat allows the instrument to receive a signal from a measurement devicein addition to the photon detector. The measurement device can be anexternal device or external sensing probe, capable of measuring orsensing a parameter other than that provided by the photon detector,such as, but not limited to, temperature, pH, dissolved gases,conductivity, reduction potential, and specific ions. The external probecan also be a multi-parametric probe capable of measuring or sensingmore than one type of parameter. In some embodiments, the measurementdevice is internal to a housing of the instrument, at least in part,wherein the communication port for communicating with the measurementdevice can also be internal to the housing of the instrument.

As to the probe assembly, in one embodiment, it comprises a plunger thatcan be pressed downward to activate the probe assembly with only onehand. This forces sealed containment chambers in the probe onto apiercing tip, thereby puncturing the seals. One of the chambers containsa dry reagent and another contains a buffer solution. When the chambers'seals are punctured, the contents of the chambers mix to form a reagentsolution. The reagent solution flows through a channel and through asample containing swab tip, causing sample to be released into thereagent. The reagent then reacts with the sample and emits lightproportional to the level of environmental contamination, by, but notlimited to, such materials as ATP, ADP or alkaline phosphatase in thesample, and the reagent chosen for the particular application. The probeassembly can be directly inserted into the instrument to measure lightemitted from the sample.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1A is an exploded perspective view of a probe assembly according toone particular embodiment of the invention, also showing the connectiontube in the interior of the probe housing, in dotted line.

FIG. 1B is a perspective view of the probe assembly of FIG. 1.

FIG. 1C is a perspective view of the probe assembly of FIG. 1 with thetest tube removed.

FIG. 2 is a diametric cross-sectional view of a portion of the probeassembly of FIG. 1 with the plunger in an “up” position.

FIG. 3 is a diametric cross-sectional view of a portion of the probeassembly of FIG. 1 with the plunger in a “down” position.

FIG. 4 is a perspective view of a detection assembly according to oneparticular embodiment of the invention with the slidable shaft in an“up” position and the hinged cover open.

FIG. 5 is a cross-sectional view of the detection assembly of FIG. 4 asviewed from the side opposite the detector housing.

FIG. 6A is a cross-sectional view of the detection assembly of FIG. 7with the slidable shaft in an “up” position with the hinged coverclosed, and with the probe assembly activated and inserted in thedetection assembly.

FIG. 6B is a diametric cross-sectional view of a portion of oneembodiment of the detection assembly showing a positioning pin formed ona hinged cover of the detection assembly.

FIG. 7 is a perspective view of the detection assembly of FIG. 4 withthe slidable shaft in an “up” position and the hinged cover closed.

FIG. 8 is a perspective view of the detection assembly of FIG. 4 withthe slidable shaft in the “down” position and the hinged cover closed.

FIG. 9 is a cross-sectional view of the detection assembly of FIG. 8with the slidable shaft in the “down” position and the hinged coverclosed, and with the probe assembly activated and inserted in thedetection assembly.

FIG. 10 is a rear perspective view of the detection assembly of FIG. 4,with the slidable shaft in the “down” position and the hinged coverclosed.

FIG. 11 is a perspective view of a measurement instrument according toone particular embodiment of the present invention, with the slidableshaft of the detection assembly in the “down” position.

FIG. 12 is a simplified block diagram schematically illustrating oneembodiment of the measurement instrument, without the sample testingdevice or photon detection assembly being shown.

FIG. 13 is a simplified block diagram of a general purpose computer foruse with various embodiments of the present invention.

FIG. 14 is a simplified block diagram of a general purpose data loggeror data transfer device for use with some embodiments of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to various embodiments of apparatus andmethods for monitoring or measuring parameters of a sample of a product,ingredient, process, or environment that can be used to provide criticalinformation that facilitates environmental and process quality in areassuch as water treatment, holding, containment and disposal systems.These settings include, but ate not limited to, testing in the food,pharmaceutical, cosmetic, and medical industries. These settings mayfurther include environmental conditioning and control equipment forgeneral usage such as, but not limited to, commercial air conditioningequipment and cooling towers. Additional settings include sensitiveenvironments potentially susceptible to malicious or inadvertentcontamination with biological materials, such as military installations,hospitals or enclosed high occupancy buildings.

Drawings depicting certain embodiments of the invention are provided forpurposes of illustration. Also, the invention is described in a contextincluding the monitoring of pathogenic contamination by measuring lightemission from a reaction. However, as one skilled in the art willappreciate, various aspects of the invention may also be applicable in avariety of other settings. Also, as will be appreciated, equivalentmodifications can be made to the invention without deviating from thescope or spirit of the invention. Not all such possible modificationshave been illustrated or described in order to avoid unnecessary detailthat would obscure the description of the invention.

FIGS. 1A, 1B, and 2 show an embodiment of a probe assembly 10 (sampletesting device) of the present invention. FIG. 1A is an exploded viewand FIG. 2 is a partial cross-sectional view of the probe assembly 10.The probe assembly 10 is used to collect sample and also serves as areaction chamber in which the sample is released into a reagentsolution. The probe assembly 10 can also serve as a device to retainsample while a parameter thereof is being measured by an instrument,such as the instrument 100 of the present invention. FIGS. 5–11 show anembodiment of the instrument 100 and a photon detection assembly 70contained therein, that can be used to measure a parameter (i.e. photoncount) of a sample contained in the probe assembly 10.

The probe assembly 10 includes a sample collection member, or swab stick12, with a hollow shaft 16, as shown in FIG. 2. The swab stick 12 has asample collection surface, or a swab tip 14. In the illustratedembodiment, the swab shaft 16, of the swab stick 12, is tubular. Also,the downward end (“upward” and “downward” being in reference to theorientation of the devices in the Figures) of the shaft 16 is open endedexposing the hollow interior of the tubular shaft 16. The swab tip 14covers the downward open end. In most embodiments, the swab tip 14 ismade of liquid permeable material, such as cotton, Dacron, poly-foam orporous liquid permeable plastic sampling surfaces to permit a reagentsolution used with the probe assembly 10 to flow out of the hollowinterior of the shaft 16 and through the swab tip 14 material, to reactwith sample collected on the swab tip 14. An upward end 18 of the swabstick 12 is secured to the rest of the probe assembly 10 by beinginserted in a connection tube 22 as best seen in FIG. 2 and describedbelow. In some embodiments, the swab tip 14 is pre-moistened to aid insample collection. In other embodiments, a dry swab tip 14 issufficient.

FIGS. 1A and 2 show that the probe assembly 10 has a probe housing 20and a connection tube 22 formed within the probe housing 20. Theconnection tube 22 has an upward end portion 30 within the probe housing20 and a downward end portion 34 joined to a downward end portion of theprobe housing 20, such as by being integrally formed therewith. This isbest seen in FIG. 2.

The downward end portion 34 of the connection tube 22 can also beintegrally formed with a tubular stub 36, the tubular stub and theconnection tube 22 being co-axially aligned. The tubular stub 36 extendsdownward away from the downward end 34 of the connection tube 22 andprobe housing 20. Also, test tube grip rings 39 can be formed on theexterior surface of the tubular stub 36, as best seen in FIG. 1A.

The connection tube 22 functions, in part, as a joining member to jointhe swab stick 12 to the probe housing. As illustrated in FIG. 2, aportion of an interior chamber 26 of the connection tube 22 is providedwith gripping members 24. The upward end 18 of the swab shaft 16 isconfigured and sized so that it can be co-axially inserted into theinterior chamber of the connection tube 22, through the downward end 34thereof, and pushed into the portion of the chamber having the grippingmembers 24 to secure the swab stick 12 to the probe housing 20. Also,the interior chamber 26 of the connection tube 22 has a reduced diameterabove the gripping members 24 to provide a seal between the swab shaft16 and the connection tube 22.

In the embodiment shown, the upward end portion 30 of the connectiontube 22 is formed with an orifice 32. In some embodiments, the orificehas a smaller diameter than the average diameter of the interior chamber26 of the connection tube. The orifice 32 provides an opening betweenthe interior chamber 26 of the connection tube 22 and the exterior ofthe connection tube. The orifice 32 is centered on the top of the upwardend portion 30 of the connection tube 22 with an opening facing upward.As can be seen in FIG. 2, a piercing tip 28 is also connected to theupward end portion 30 of the connection tube 22. In some embodiments,the piercing tip 28 is disposed directly above the orifice 32 by beingformed on projection members that are joined at one end to theconnection tube 22, with the other ends thereof extending over theorifice whereupon the piercing tip 28 is formed.

The probe assembly 10 has a plunger 44, or displacement member, that isslideably connected to the probe housing 20 and can be actuated, orpushed, to activate the probe assembly 10. See FIGS. 1A and 2. Theplunger 44 has a liquid chamber 46. In one embodiment, the liquidchamber 46 contains a liquid buffer and detergent, and the liquid issealed in the liquid chamber 46 by a foil seal 48 at the downward end ofthe plunger 44. In other embodiments, the liquid chamber may containdifferent reagents. The plunger 44 also has a hollow retaining cavity 47that opens upward and can be used to retain the probe assembly inposition by an instrument with a pin that is inserted in the cavity.

As best seen in FIGS. 2 and 3, the plunger 44 can be in an “up”position, prior to activation of the probe assembly, wherein no reactionhas yet occurred in the probe assembly 10, or pushed downward to a“down” position. When the plunger is pushed downward, or actuated, tothe “down” position, the piercing tip 28 pierces the foil seal 48 of theliquid chamber 46 as well as foil seals 42 of a dry chamber 38,containing reagent, disposed below the plunger 44. It is also noted thatthe plunger 44 has seal rings 45 that mate with the interior surface ofthe probe housing 20 to prevent liquid, released from the liquidchamber, from leaking past the plunger 44 to the exterior of the probeassembly 10.

The dry reagent chamber 38, which may contain one or more reagents anddesiccant, is disposed within the probe housing 20, under the plunger44. The dry chamber 38 has foil seals 42 to seal the top and bottom ofthe chamber 38, with reagent sealed therewithin. There may be one ormore positioners 40 longitudinally formed on the exterior surface of thedry chamber 38. The positioners 40 may, for example, take the form ofribs. See FIG. 1A. The positioners 40 are configured to engage theinterior surface of the probe housing 20 and retain the dry chamber 38in position above the piercing tip 28 while the plunger 44 is in the“up” position, but to permit the dry chamber 38 to slide downward pastthe piercing tip 28 when the plunger 44 is being displaced to the “down”position, thus breaking the foil seals 42.

In some embodiments, the dry chamber 38 and the liquid chamber 46 may bereversed in position. That is, chamber 46 may hold dry reagent, or acomponent of a reagent, and chamber 38 may hold a liquid reagent, orliquid component of a reagent. In other embodiments, both chambers maycontain liquids. Furthermore, the components of a reagent solution thatis selected for a particular application may be distributed throughoutthe chambers 38, 46 in various ways. For example, one chamber cancontain a medium or buffering solution while the other contains areacting reagent to facilitate energy emission from the sample. Also,some embodiments of the invention can comprise one chamber or more thantwo chambers. In a further embodiment, one chamber may contain a growthpromotion medium and another may contain a stabilization or transportmedium. These may be used together or separately.

An annular cap 50 is fitted over the probe housing 20 and plunger 44. Asbest seen in FIG. 2, a lower portion 52 of the cap is configured to matewith the exterior surface of the probe housing 20 at the upper end ofthe housing and an upper portion 54 of the cap 50 mates with theexterior surface of the plunger 44. The plunger 44 is slidable inrelation to the cap 50 while the probe housing 20 is securely mated tothe cap 50. Also, there are small restriction devices 56 associated withthe surface of the plunger 44 and engage the upper end of the cap 50 tohold the plunger 44 in the “up” position until a user activates theprobe by depressing the plunger 44.

A translucent test tube 58 is provided for the probe assembly 10. Thetest tube 58 serves to protect the unused sampling device, to contain asample containing device or to accumulate, activated sample and reagent,and as a measurement chamber. See FIGS. 1A, 1B and 2. When the probeassembly 10 is fully assembled and ready to activate, the test tube isfit over the swab stick 12 so that the swab tip 14 is contained withinthe test tube 58. See FIG. 1B. The diameter of an upper portion of thetest tube 58 is sized to fit snugly over the test tube grip rings 39 onthe tubular stub 36, such that when the test tube 58 is pushed over thetubular stub, a sufficiently tight fit is accomplished to securelycouple the test tube 58 to the tubular stub 36.

As shown in FIG. 1A, there is also an atmospheric vent 60 comprised of agaps in the grip protrusions 39 of the tubular stub 36 and upper edge ofthe test tube 58. This provides a vent to the atmosphere from theinterior of the probe assembly 10, to release pressure buildup from theprobe assembly when the plunger 44 is depressed. When the plunger 44 isdepressed during activation of the probe, a pressure gradient is thuscreated between a high pressure point near the plunger 44, and a lowpressure point at the atmospheric vent 60. This ensures that fluid flowsfrom a point near the plunger 44 into the test tube 58.

In operation, the test tube 58 is removed from the probe, to expose theswab tip 14 for sample collection without removal from the connectionTable 22, as shown in FIG. 1C. A user then uses the swab tip 14 tocontact a sample surface. The test tube 58 is then replaced over theswab stick 12 and the upper end portion of the tube 58 is pushed overthe tubular stub 36 to secure the test tube in place. To activate theprobe, a downward force, sufficiently supplied by a user's hand orfinger, is applied to the plunger 44 to drive it toward the piercing tip28 thus breaking the foil seals 42, 48 of the dry chamber 38 and liquidchamber 46. The plunger 44 is displaced from the “up” position to the“down” position, as shown in FIGS. 2 and 3. The liquid buffer solutionfrom the liquid chamber 46 and the reagent from the dry chamber 38 arereleased and mix. The reagent solution is forced through the orifice 32at the upward end portion 30 of the connection tube, into the hollowshaft 16 of the swab stick 12 by the downward thrust of the plunger 44.The arrows labeled (“A”) in FIG. 3 indicate one portion of the fluidflow path through the channel defined by the hollow shaft 16. Thepressure build up created by the downward thrust of the plunger isreleased through the atmospheric vent 60, maintaining a pressuregradient that drives or propels the reagent solution downward throughthe flow path indicated by arrow (“B,”) in the shaft 16 of the swabstick 12. The fluid exits the swab shaft 16 through the swab tip 14 thuscontacting the collected sample and releasing some, or all, of thesample into the reagent solution. The reagent solution containingreleased sample then accumulates in the distal end of the test tube 58.

The distal end of the test tube serves as a measurement portion of theprobe assembly 10 that, in some embodiments of the invention, is exposedto a photon detection device. The reagent and the sample react toproduce light proportional to the amount of ATP, ADP, alkalinephosphatase or other suitable analyte in the sample. The instrument 100,which includes a photon detection device, such as the detection assembly70 described below and illustrated in FIGS. 4–10, is used to measurelight emitted from the reagent solution to provide an indication oflevel of contamination in the environment sampled. The configuration ofthe probe assembly 10, with the plunger 44, orifice 32, and fluidchannels formed in part by the swab shaft 16, ensure that displacementof the plunger drives substantially all, or a sufficient amount of thereagent solution and sample into the measurement portion of the probe(distal end of the test tube 58) without the need for further action,such as shaking.

The following provides a summary of some of the features of the probeassembly 10 that contribute to precision, accuracy, reliability, andease-of-use of various embodiments of the present invention. Forexample, the seals 42, 48 on the dry chamber 38 and liquid chamber 46,are not contacted by the swab tip 14 during activation of the probeassembly 10. This is in contrast to certain devices currently availablethat require the swab to be used to pierce membranes of reagentchambers. This present invention thus prevents sample from being removedfrom the swab tip 14 due to contact with the seals of the reagentchambers. Also, the probe assembly 10 of the invention is easy toactivate with only one hand, by depressing the plunger 44. It also doesnot require shaking to mix the reagent with the liquid buffer solutionas it is sufficiently mixed by the geometry of the probe assembly 10.For example, the reagent solution is adequately mixed by the release ofthe liquid and reagent, combined with the turbulent flow of the mixturethrough the orifice 32, and into and through the swab shaft 16, orchannel, and through the swab tip 14. The amount of reagent isautomatically, precisely, and accurately provided and dispensed by usingonly one hand to activate the probe. Also, in one embodiment, the probeassembly 10 is configured so that the swab tip 14 is above the bottomportion of the test tube 58 that is placed in the reading area of aphoton detection device, or the photon sensing path. This can be seen inFIG. 9, wherein the circular opening 96 (a shutter 82 opening)approximates the photon sensing path of the photon detection device.Note that the swab tip 14 is just above this reading area. At the sametime, the probe assembly 10 is configured to dispense a sufficientamount of liquid so that the liquid level 98 in the test tube 58 isnonetheless high enough to maintain liquid contact, or communication,with the swab tip 14. This can also be seen in FIG. 9. Thisconfiguration permits a photon detection device to measure light emittedfrom the solution with minimal interference from the swab tip 14, whilethe liquid is still able to liberate sample from the swab tip 14. Theprobe assembly 10 is also designed to eliminate reagent leakage, whichdecreases measurement precision and can contaminate the sampled surface,due to the various seals described above.

The method by which the probe assembly 10 is operated, fully integratesthe operations of piercing barriers between separate reagentcompartments, mixing said reagents, and dispensing with precision, knownamounts of said mixed reagents, and finally, releasing the samplecontaining material for detection. The integrated piercing, transferringand channeling mechanism which sequentially performs the steps ofactivation, mixing and dispensing of all reagents through the samplingdevice avoids piercing reagent separation barriers with the samplecontaining surface, and resultant loss of sample on barrier debris, lossof reagent materials in voids or open cavities of the device, andrequiring the operator to shake, screw or repetitively manipulate thedevice to ensure proper operation. It is also noted that the test tube58, or measurement chamber, forms a continuous collection and readingchamber that is optically uniform and conducive to efficiencyphotometric measurement. This enhances photon transmission for moreaccurate, precise, and sensitive readings.

Certain embodiments of the instrument 100 of the present inventioncomprise an instrument housing 101, within which the photon detectionassembly 70 is contained. See FIGS. 11 and 12. FIG. 11 is an isometricview of the exterior of an embodiment of the instrument 100 with theinstrument housing 101 shown and FIG. 12 is a block diagram of anembodiment of the instrument 100, showing an external measurement device107 (a multi-parametric external probe is represented by the embodimentillustrated in FIG. 12), but without the photon detection assembly 70 orprobe assembly 10 (sample testing device) being shown. Said externalmeasurement device may be fixed or detachable from instrument 100without impacting it's functionality. In FIG. 11 a top portion of thephoton detection assembly 70 can be seen, with the rest of the detectionassembly contained in the instrument housing 101.

The instrument 100 can include a key pad 102, or control panel, adisplay screen 104, a processor 106, and one or more communication ports108. The communication ports 108 can comprise any variety of inputand/or output devices, either internal to the instrument or external,for use either with measurement devices 107, or other external devices.In other embodiments, the instrument also comprises an internal systemmemory 110. In yet another embodiment, the instrument comprises areceiving device 113 for receiving and reading external memory devices112, such as, but not limited to, memory cards and CD-ROM disks. Inaddition, other forms of external memory can be used with the instrument100 by transferring data to or from the external memory through thecommunication ports 108. These other forms of external memory cancomprise hard disks on general purpose computer systems 120 (describedbelow), data loggers 140, or other types of remote databases 136.

The instrument 100 can be configured to receive signals from both aphoton detection device of the photon detection assembly 70, whichincludes a photomultiplier tube, photodiode or other photon sensingdetector, and other measurement devices 107 that can communicate withthe instrument 100 through the communication port 108 thereof. See FIG.12. As described, the measurement devices 107 may be external to theinstrument 100 or be an integral part thereof. Such measurement devices107, include, but are not limited to, external single ormulti-parametric probes for monitoring other parameters essential toenvironmental safety or HACCP (Hazard Analysis and Critical ControlPoint) principles, such as, but not limited to, pH, temperature,dissolved gases, conductivity, reduction potential, and specific ions.One example multi-parametric probe is a combined temperature and pHprobe, capable of providing measurements for both parameterssimultaneously, or separately. A variety of multi-parametric (as well assingle parametric) probes are currently available and widely used andcan include the ability to measure a number of the parameters listed.For example, combined temperature/pH probes are widely used, as well asprobes able to measure more than two parameters. One example ismulti-parametric probes currently widely available and capable ofmeasuring pH, conductivity, temperature, pressure, and dissolved gases.Although the measurement device 107 represented in FIG. 12 is a probe, amyriad of other measurement devices can be substituted therefor.

The embodiments of the instrument 100 described above combine theability to accurately, precisely, and efficiently measure luminescenceparameters (which are often selected as CCP indicators in HACCP plans)with the photon detection assembly 70, with the ability to measure,compile, and analyze other parameters in conjunction with the measuredluminescence parameters, using the same instrument 100. These otherparameters, not necessarily related to light emission, are oftenselected as indicators for the same or different CCPs for which theluminescence parameters serve as indicators, with all the parametersbeing critical to a HACCP plan. This combined functionality of theinstrument 100 is unique and provides many significant advantages. Theadvantages are highly apparent for food and environmental controlapplications where HACCP based standards are prevalent and luminescenceis very relevant, but the same or equivalent modifications of theinstrument 100 can also be used in a variety of other settings toprovide significant benefits.

As to the food industry, the significant need for the capabilities ofthe present invention arise, in part, from the need to comply with HACCPbased standards or regulations. In order to do so, the food processor,or food manufacturer, must be able to identify (critical control points)CCPs. CCPs are points, steps, or procedures where some form of controlcan be applied and a food safety hazard can be prevented, eliminated, orreduced. The processor may need to measure a variety of parametricindicators for each CCP (e.g. time and temperature measurements toverify a cooking process), identify deviations, perform trend analysisof deviations, and document the data to show compliance with the HACCPrequirements. In carrying out a HACCP plan, a food processor iscurrently likely to use many single-function monitors to take isolatedmeasurements (e.g. a temperature probe, a pH meter, and a separatephoton counter to measure bioluminescence of an activated sample) andthen to enter the readings manually on different data collection sheets.Such collection procedures are tedious, inefficient, and highly subjectto human error. A serious risk of loss of data integrity by willful ornegligent action by those involved in the data collection exists withthe current state-of-the-art. In addition, examination of therelationship of multiple parameters to the quality of the productionenvironment is difficult. The present invention solves these problems,as is further illustrated by an example embodiment described below.

In one example embodiment of the invention, the instrument 100 comprisesa photon detection assembly 70 with a photo multiplier tube (PMT) orphotodiode and is capable of communicating with a multi-parametric probe(i.e. an external measurement device 107) for measuring temperature andpH of an environment from which the sample is taken. Each of thedifferent parameters to be measured, photon count, pH, and temperature,are critical indicators for the same CCP (or different CCPs) in an HACCPplan.

In this example embodiment, a user can use the instrument to measurephoton count of a sample, store the photon count measurement temporarilyor permanently on the instrument 100, and then use the instrument 100and the multi-parametric probe 107 to read and store either temperatureor pH, or both, of the relevant environment. The measurements of thevarious parameters can be taken simultaneously or sequentially. The datarepresenting all the different parameters measured can be simultaneouslyviewed and compared on the display screen 104 of the instrument 100,without having to switch between different data collection sheets, orany otherwise separate data format.

In a preferred embodiment, the data collected is randomly allocated tothe data storage facility in a manner that optimizes the amount of dataretained but with full flexibility by the operator to assign any amountof data storage independent to any parameter of interest. In a mostpreferred embodiment, all such data is retained in its designatedlocation in such a manner that willful or negligent of the primary datais precluded.

Previously, a user would have had to separately take and record thephoton count of a sample, and then the pH or temperature of theenvironment. These data were manually recorded or logged in independentunrelated instruments. In order to view or analyze the photon count datatogether with the temperature and pH data, the user would have had toimport it all into a single format, possibly by manually copying orentering it into a common database if it were recorded on datacollection sheets. By contrast, with the instrument 100, all of the datarepresenting the different parameters, including photon count, isintegrated by being collected, recorded, and displayed by one device.

In the example embodiment, software is provided on the instrument 100 toanalyze the integrated data (photon count, temperature, and pH) todetermine whether critical limits for a CCP have been reached thatrequire corrective action to comply with the HACCP plan. The software isstored on the memory 110 and drives the processor 106 of the instrument100. If the critical limit(s) is trend sensitive to a combinedinteraction of the three separate parameters, the measured data can beanalyzed in connection with a previous trend stored on the memory 110 ofthe instrument 100. The software can also generate a display format onthe display screen 104 conducive to quick assessment of the relevant CCPor other factor (e.g. trending the data and displaying it in agraph(s)). None of these capabilities is currently available with aninstrument that also has the capacity to measure bioluminescentparameters.

As can be seen from the above example, certain embodiments of theinstrument 100 efficiently combine information from several distinct butrelated parameters, which can include photon measurement, to provide amore comprehensive, integrated, and efficient evaluation of a CCP orgroups of related CCPs, or any other environmental or process condition.A further benefit of the instrument is that measurement of multipleparameters utilizing one instrument eliminates the high cost ofprocuring several measuring instruments. An additional benefit is theelimination of the potential for description of data integrity duringsampling, transport, transcription or analysis of CCP compliance to theAACCP Plan.

As will be appreciated by one skilled in the relevant art, variousequivalent modifications can be made to the above example embodiment ofthe instrument 100 without deviating from the scope of the invention.Portions of the software or hardware, or the associated method steps forusing the same, can be left out or combined differently, or variousequivalent modifications of the same can be added. For example, a myriadof different external measurement devices 107 can be used in place ofthe temperature/pH probe, such devices comprising those being capable ofmeasuring such parameters as dissolved gases, conductivity, reductionpotential, and specific ions. The external measurement device 107 willbe selecting depending on the application. Also, the integrated datacould be exported to a general-purpose computer (described below), viathe communication port(s) 108, for analysis with software, in place of,or in addition to, analysis within the instrument 100.

The communication port 108 of the instrument 100 can provide for directconnection to a computer, a data transfer device, or other data analysisdevice for comprehensive data compilation and output. FIG. 13 is a blockdiagram of a general-purpose computer for use with some embodiments ofthe present invention. The computer system 120 includes a centralprocessing unit (CPU) 122, a display screen 124, an internal systemmemory 126, and input/output devices 128. In addition, the computer 120includes a receiving device 130 for receiving and readingcomputer-readable media 132, such as a diskette. Although thecomputer-readable media 132 is represented in FIG. 13 as a CD-ROM disk,the computer system 120 can employ other computer-readable media,including but not limited to, floppy disks, tape, flash memory, systemmemory 126, DVD-ROM, and hard drives. The input/output 128 can beconnected to a variety of devices, including a keyboard 134, or remoteor external database 136, or mouse (not shown). In addition, remotedevices that send and receive signals can also communicate with thecomputer system 120 through these input/outputs 128, such as, but notlimited to, other devices within a network, modems, data loggers 140,personal data devices, or palm pilots. Software used with the computer120 to analyze data collected by the instrument 100 can include thecapabilities of the software described above for the instrument 100. Inaddition, such software, like the software for the instrument 100, canalso provide a myriad of other functions, such as, for example, beingcapable of assessing and monitoring compliance with the overall HACCPplan, or other quality control or safety program, such as a statisticalprocess control program. Such software may be internal to instrument100, external to instrument 100 or a combination of internal andexternal.

FIG. 14 is a simplified block diagram of a general purpose data logger140 referenced above, that can be used to supply data or record datafrom a variety of sources, such as the instrument 100, measurementdevice 107, or the general purpose computer system 120. The embodimentillustrated in FIG. 14 comprises input and/or output devices 142, ananalog to digital converter 144, a processing unit 146, a display 148, akeypad 150, and an internal memory 152.

FIGS. 4 and 5 illustrate an embodiment of the instrument 100 comprisingthe photon detection assembly 70. The photon detection assembly 70includes a slidable shaft 72, a rotatable member, or rotatable shaft 80,a holding member, or holding chamber 76, with a hinged cover 74, ashutter 82, and a detector housing 86 containing, in one embodiment, aphoto-multiplier tube (PMT) or photo device for photon detection (thePMT is not shown).

The slidable shaft 72 has an interior chamber 84 configured to receivethe probe assembly 10, or a similar device. When it is desired tomeasure light emitted from the activated probe assembly 10, it isinserted into the detection assembly 70 through the holding chamber 76,with a portion of the probe extending into the interior chamber 84 ofthe slidable shaft 72.

The holding chamber 76 is joined to the top portion of the slidableshaft 72. The hinged cover 74 is connected to the holding chamber 76 andis pivotable between an “open” and “closed” position. The hinged cover74 is configured to prevent light from entering the interior chamber 84of the slidable shaft 72 when it is adjusted to a “closed” position overthe interior chamber 84. FIG. 4 shows the hinged cover open and FIG. 7shows the hinged cover closed.

FIGS. 6A and 6B show the probe assembly 10 inserted in the slidableshaft 72 with the hinged cover 74 closed. As can be seen, the holdingchamber 76 of the assembly 70 is configured to hold the plunger 44,probe housing 20, and cap 50 of the probe assembly 10. Near the bottomof the holding chamber 76, a substantially horizontal holding surface 78extends inward from the interior wall of the chamber to mate against thebottom surface of the probe housing 20 surrounding the tubular stub 36.This holds the probe assembly 10 so that the test tube 58, and anysample contained therein, remains above the bottom of the detectionassembly 70. In some embodiments the holding member, (or holding chamber76) illustrated in FIGS. 6A and 6B is substituted with a holding chamberthat can directly contain the sample rather than a portion of a testingdevice containing the sample. For example, the sample containing chambercan be within the holding chamber, or integral therewith.

As best seen in FIGS. 7 and 8, the slidable shaft 72 is verticallyslidable in relation to a shaft housing 90. The shaft housing 90 and acoil spring 88 comprise an elevator mechanism for the shaft 72. Theslidable shaft 72 and the shaft housing 90 are vertically and co-axiallyaligned. The bottom end of the coil spring 88 is set against the top endof the shaft housing 90 so that the coil spring 88 extends upward fromthe top of the shaft housing 90. The slidable shaft 72 is containedconcentrically within the coil spring 88, with the upper end of the coilspring mated against the bottom of the exterior surface of the holdingchamber 76. The slidable shaft 72, and the holding chamber 70 attachedthereto, can be depressed from an “up” position to a “down” position, asshown in FIGS. 7 and 8. When in the “down” position shown in FIG. 8, theslidable shaft 72 can be locked in position using a releasable lockingmechanism (not shown). When the locking mechanism is released, the coilspring 88 returns, or propels, the slidable shaft to the “up” position.

As shown in FIGS. 6 and 7, the rotatable shaft 80 is concentricallydisposed within a cylindrical positioner 94 formed at the bottom portionof the slidable shaft 72. The exterior surface of the rotatable shaft 80is lined with grooves 92 that form a downward cork screw or helicalpattern on the rotatable shaft. The interior surface of the positioner94 has guide members configured to fit within the grooves. The rotatableshaft 80 is free to rotate and is connected to the shutter 82, whichrotates with the rotatable shaft. When slidable shaft 72 is verticallydisplaced, the positioner 94 is also vertically displaced, causing theguide members of the positioner to travel along the grooves. However,the positioner 94 is configured to travel vertically only, and does notrotate, and as such, causes the rotatable shaft 80 to rotate. In turn,the shutter 82 also rotates as it is coupled to the rotatable shaft andfree to rotate with the shaft.

In the embodiment illustrated in FIGS. 4 and 9, the shutter 82 is acylindrically shaped member, adjacent the detector housing 86 containingthe PMT. When the slidable shaft 72 is in the “up” position and thehinged cover 74 is open, as shown in FIG. 4, the shutter 82 is in a“closed” position, with an opening 96 of the shutter facing away fromthe detector housing 86. As such, the PMT is not exposed to externallight entering from the open holding chamber 76, which could interferewith the precision and accuracy of the readings taken. The “up” positionis a sample containing device loading position. When the slidable shaft72 is displaced downward, the shutter rotates so that the opening 96faces toward the detector housing 86 to permit a photon source in thedetection assembly 70, such as a reacting sample in the probe assembly10, to be detected by the photon detecting device. See FIG. 9. The“down” position is a sample measurement position. The detection assembly70 thus provides a dark chamber 91 formed partially by the detectorhousing 86 and the shutter 82, that is photometrically stabilized priorto a reading (count), or measurement being taken, and also preventsexternal light from being detected by the photon detecting device duringthe reading. See FIG. 10.

It is also noted that the in some embodiments, the hinged cover 74 mustbe closed before the slidable shaft 72 can be displaced downward to theextent that the shutter 82 is open. This ensures that the photondetecting device is not exposed to external light. In one embodiment, asbest seen in FIG. 11, the cover 74 is prevented from being opened by theinstrument housing 101, when the slidable shaft 72 is in the “down”position.

During use, the locking mechanism for the slidable shaft 72 is releasedto allow the slidable shaft to be lifted into the “up” position by thecoil spring 88, and the hinged cover 74 is opened, as shown in FIG. 4.An activated sample device, such as the probe assembly 10, is placedinto the detection assembly and the hinged cover is closed. See FIGS. 6Aand 6B. The slidable shaft 72 is then depressed to move the distal endof the test tube 58, in which the reacting sample is contained, into thedetection, or measurement path of the photon detecting device. At thesame time, the shutter 82 is rotated open to expose the reacting sampleto the photon detecting device, as previously described. FIG. 9 showsthe detection assembly in the “down” position with light from thereacting sample exposed to the photon detecting device. As can be seen,only the distal end of the test tube 58 containing the reacting sampleis exposed through the opening 96 of the shutter 82. The swab tip 14 ismaintained above the opening 96, but is still in contact with theliquid, having a liquid level 98. Again, as described earlier, thisminimizes reading interferences from the swab tip 14, while maintainingthe swab tip 14 in contact with the liquid to leech sample from the swabtip 14.

In another embodiment of the detection assembly 70, a positioning pin73, or positioning member, in the hinged cover 74 mates with theretaining cavity 47 in the plunger 44 to align the probe assembly 10 inthe dark chamber 91. See FIG. 6B. This helps to reproducibly positionthe probe in very close and exact proximity to the detector, but withoutthe swab tip 14 being in the direct light measurement path and allowsfor the more accurate, sensitive readings compared to other availablesystems. Various embodiments of the hinged cover 74 can be constructedto permit the pin to engage the plunger 44 in this manner. For example,the hinged cover 74 could be independently slidable in relation to theholding chamber 76, in a vertical direction to raise the pin above theretaining cavity 47 before sliding the cap downward to engage the pin inthe cavity 47.

As discussed previously, in some embodiments, the photon detectionassembly 70 is contained within an instrument housing 101 of theinstrument 100. FIG. 11 shows an embodiment of the instrument housing101 containing the photon detection assembly 70, with the slidable shaft72 in the “down” position for taking a reading of the sample. In thisposition, only the top of the photon detection assembly 70, comprisingthe hinged cover 74, is visible, with the rest of the detection assemblycontained within the instrument housing.

Various reagents can be used with the embodiments of the invention. Someembodiments employ a reagent in dry form having a composition thatenhances dissolution of a pellet upon device activation. Also, variousliquids/solutions can be selected for use with the embodiments of theinvention depending on the particular application and reagent used. Thecomposition of the reagents and liquids are beyond the scope of thisinvention.

The various embodiments described above can be combined to providefurther embodiments. All of the above U.S. patents, U.S. patentapplication publications, U.S. patent applications, foreign patents,foreign patent applications and non-patent publications referred to inthis specification and/or listed in the Application Data Sheet,including but not limited to U.S. patent application Ser. No.60/338,844, filed Dec. 6, 2001, and titled “SAMPLE COLLECTION ANDTESTING SYSTEM” are incorporated herein by reference in their entirety.Aspects of the invention can be modified, if necessary, to employsystems, circuits and concepts of the various patents, applications andpublications to provide yet further embodiments of the invention.

Although specific embodiments, and examples for the invention aredescribed herein for illustrative purposes, various equivalentmodifications can be made without departing from the spirit and scope ofthe invention, as will be recognized by those skilled in the relevantart. The teachings provided herein of the invention can be applied towide variety of applications as noted. The various embodiments describedcan be combined to provide further embodiments. The described devicesand methods can omit some elements or acts, can add other elements oracts, or can combine the elements or execute the acts in a differentorder than described, to achieve various advantages of the invention.

These and other changes can be made to the invention in light of theabove detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification. Accordingly, theinvention is not limited by the disclosure, but instead its scope isdetermined entirely by the following claims.

1. An instrument for use in monitoring a product, an ingredient, anenvironment or process, the instrument comprising: a photon detectionassembly with a photon detector and a dark chamber; a communication portcapable of receiving a signal from an additional measurement deviceother than the photon detector of the photon detection assembly, thesignal corresponding to a parameter determined by the additionalmeasurement device; and a processor operable to integrate the parameterwith information received from the photon detector into integrated data.2. The instrument of claim 1 wherein the additional measurement deviceis capable of measuring at least one of ATP level, ADP level, AMP level,alkaline phosphatase level, pH, temperature, dissolved gases,conductivity, microbiological count, and specific ions.
 3. Theinstrument of claim 1 wherein the photon detector is a photon countercomprising a photo-multiplier tube or photodiode.
 4. The instrument ofclaim 3 wherein the dark chamber has a shutter member rotatablypositionable to be open or closed, a cylindrical holding member with aslidable shaft for positioning the sample and the shutter in closeproximity to the detector when open, and a cover that opens to admit thesample but must be closed to measure the sample.
 5. The instrument ofclaim 3 wherein the additional measurement device is an external probe,which may be fixed or removable from the instrument.
 6. The instrumentof claim 5 wherein the external probe is interchangeable with otherexternal probes.
 7. The instrument of claim 5 wherein the external probeis capable of measuring different parameters.
 8. The instrument of claim5 wherein the external probe is capable of measuring a single parameterdifferent from the photon detector.
 9. The instrument of claim 7 whereinthe external probe is capable of measuring different parameterssimultaneously.
 10. The instrument of claim 7 wherein the differentparameters include at least one of temperature, pH, dissolved gases,conductivity, and specific ions.
 11. A monitoring instrument,comprising: a photon device; a reading chamber for retaining a lightemitting sample to be analyzed using the photon device; a communicationport that allows the instrument to receive a signal from an additionalmeasurement device, the measurement device being capable of measuring aparameter other than photon count; and a processor operable to integratethe received parameter with information received from the photon deviceinto integrated data.
 12. The instrument of claim 11 wherein theadditional measurement device comprises an external probe.
 13. Theinstrument of claim 11 wherein the additional measurement devicecomprises an external probe which is capable of measuring at least oneof temperature, pH, dissolved gases, conductivity, reduction potential,and specific ions.
 14. The instrument of claim 12 wherein the externalprobe is capable of measuring a plurality of different parameters. 15.The instrument of claim 12 wherein the external probe is capable ofmeasuring a single different parameter.
 16. The instrument of claim 14wherein at least one of the plurality of different parameters istemperature, pH, dissolved gases, conductivity, reduction potential, orspecific ions.
 17. The instrument of claim 11 wherein the communicationport is capable of receiving signals from any of a plurality ofinterchangeable measurement devices.
 18. The instrument of claim 17,wherein the plurality of interchangeable measurement devices comprisedevices for measuring different parameters.
 19. The instrument of claim17 wherein the plurality of interchangeable measurement devices comprisean external probe, which may be fixed or detachable from the instrument.20. The instrument of claim 17 wherein the plurality of interchangeablemeasurement devices comprise a plurality of external probes, with atleast two of the external probes being capable of measuring differentparameters.
 21. The instrument of claim 20 wherein at least one of theexternal probes is capable of measuring temperature, pH, dissolvedgases, conductivity, reduction potential, or specific ions.
 22. Theinstrument of claim 11 wherein the instrument comprises a plurality ofcommunication ports each capable of receiving a signal from a separatemeasurement device.
 23. The instrument of claim 22 wherein at least oneof the communication ports is capable of communicating with a generalpurpose computer.
 24. The instrument of claim 23 wherein at least one ofthe communication ports is capable of communicating with a data logger.25. The instrument of claim 23 wherein at least one of the communicationports is capable of communicating with an external memory system. 26.The instrument of claim 22 wherein at least two of the separatemeasurement devices measure different parameters.
 27. The instrument ofclaim 26 wherein at least one of the separate measurement devices is anexternal probe.
 28. The instrument of claim 27 wherein the externalprobe is capable of measuring temperature, pH, dissolved gases,conductivity, reduction potential, or specific ions.
 29. A method ofmonitoring a sample of a product, an ingredient, a process, or anenvironment comprising: providing an instrument having a photon detectorand a communication port for communicating with a measurement device,the measurement device being capable of measuring a parameter inaddition to a parameter measured by the photon detector; providing themeasurement device to be coupled to the instrument through thecommunication port; collecting a sample from the environment, process,product or ingredient, and placing the sample in a chamber for analysisusing the photon detector; analyzing the sample using the photondetector; measuring a parameter of the product, the ingredient, theenvironment or process using the measurement device; communicating theparameter to the instrument via the communication port; and integratingthe received parameter with information received from the photondetector into integrated data.
 30. The method of claim 29 wherein datareceived from the photon detector and the measurement device representsselected CCP indicators.
 31. The method of claim 30 further comprisinganalyzing the data using a processor of the instrument to correlate to aCCP limit.
 32. The method of claim 29 further comprising displaying datafrom the photon detector and the measurement device on a display deviceof the instrument.
 33. The method of claim 32 further comprisingdisplaying data from the instrument in graphical or chart form tofacilitate data analysis, the display of that data and the analysisthereof being carried out by a processor of the instrument or anexternal processor.
 34. The method of claim 29 further comprisingrecording data from the photon detector and the measurement device on amemory of the instrument.
 35. The method of claim 29 further comprisingrecording data from the instrument in a random access configuration suchthat the user may allocate any amount of memory to each parameter beingmeasured.
 36. The method of claim 29 wherein the instrument comprises aplurality of communication ports and at least one of the communicationports is used to transfer data received from the photon detector and themeasurement device to an external device.
 37. The method of claim 35wherein the external device comprises a processor used to analyze therecorded data.
 38. The method of claim 36 wherein the external device isa general purpose computer.
 39. The method of claim 36 wherein theexternal device comprises a data storage device.
 40. The method of claim39 wherein the external device is a general purpose computer and thedata storage device is a hard disk coupled to the general purposecomputer.
 41. The method of claim 29 further comprising using aprocessor of the instrument to analyze data received from the photondetector and the measurement device.
 42. The method of claim 41 whereinusing the processor to analyze the data comprises providing software tobe used with the instrument processor to indicate correlation with a CCPlimit.
 43. The method of claim 41 wherein the processor used to analyzethe data may be internal to the instrument, external to the instrument,or any combination thereof.
 44. The method of claim 29 wherein measuringa parameter of the process or environment using the instrument comprisesproviding a measurement proportional to at least one of ATP level, ADPlevel, alkaline phosphatase level, temperature, conductivity, pH,dissolved gases, specific ions, and microbiological count.
 45. Theinstrument of claim 1, further comprising a memory wherein at least theintegrated data is stored.
 46. The instrument of claim 1, furthercomprising a display wherein at least the integrated data is displayed.47. The instrument of claim 1, further comprising: a memory wherein atleast the integrated data and previous integrated data is stored; and adisplay wherein at least the integrated data trended with the previousintegrated data is displayed.
 48. The instrument of claim 1, furthercomprising the additional measurement device wherein the parameter fromthe additional measurement device and the information received from thephoton detector are concurrently collected.
 49. The instrument of claim1, further comprising a plurality of additional measurement deviceswherein a plurality of parameters from the additional measurementdevices and the information received from the photon detector areconcurrently collected.
 50. The instrument of claim 11, furthercomprising a memory wherein at least the integrated data is stored. 51.The instrument of claim 11, further comprising a display wherein atleast the integrated data is displayed.
 52. The instrument of claim 11,further comprising: a memory wherein at least the integrated data andprevious integrated data is stored; and a display wherein at least theintegrated data trended with the previous integrated data is displayed.53. The instrument of claim 11, further comprising a second measurementdevice wherein a second parameter from the second measurement device,the information received from the photon device and the parameterreceived from the additional measurement device are integrated into theintegrated data.
 54. A method of sampling of a product, an ingredient, aprocess or environment using a sampling instrument, the methodcomprising: analyzing a sample using a photon detector residing in thesampling instrument, the sample collected from the product, theingredient, the process, or the environment; receiving a signal from ameasurement device, the measurement device being capable of measuring aparameter other than a photon count and the signal comprisinginformation corresponding to the measured parameter; integrating theinformation corresponding to the measured parameter with informationreceived from the photon detector into integrated data; and storing theintegrated data into a memory residing in the sampling instrument. 55.The method of claim 54, further comprising measuring the parameter usingthe measurement device, wherein the measurement device resides in thesampling instrument.
 56. The method of claim 54, further comprising:measuring the parameter using the measurement device, wherein themeasurement device is external to the sampling instrument; andcommunicating the signal to the sampling instrument from the externalmeasurement device.
 57. The method of claim 54, further comprising:measuring a second parameter using an external measurement device thatis external to the sampling instrument; communicating a second signal tothe sampling instrument from the external measurement device, the secondsignal comprising information corresponding to the second parameter; andintegrating the information corresponding to the second parameter, theinformation received from the photon detector, and the informationreceived from the measurement device into the integrated data.
 58. Themethod of claim 54, further comprising displaying the integrated data ona display residing on the sampling instrument.
 59. The method of claim54, wherein data received from the photon detector and the measurementdevice represents selected CCP indicators.
 60. The method of claim 54further comprising analyzing the integrated data using a processor ofthe sampling instrument to correlate to a CCP limit.
 61. The method ofclaim 54 wherein the received signal comprises at least one selectedfrom a group consisting of a measurement proportional to at least one ofan ATP level, an ADP level, an alkaline phosphatase level, atemperature, a conductivity, a pH, a dissolved gases, a specific ion,and a microbiological count.